CLINIQUE SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25- avobenzone, octisalate, octocrylene, and oxybenzone cream

CLINIQUE by

Drug Labeling and Warnings

CLINIQUE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3.0%
Octisalate 5.0%
Octocrylene 1.3%
Oxybenzone 5.0%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water dimethicone butylene glycol butyloctyl salicylate isononyl isononanoate polyester-8 silica glycerin polysilicone-11 triticum vulgare (wheat bran) extract algae extract laminaria saccharina extract olea europaea (olive) fruit extract coffea robusta seed extract echinacea pallida (coneflower) extract rosmarinus officinalis (rosemary) extract sea whip extract astrocaryum murumuru seed butter adenosine phosphate trehalose disodium nadh padina pavonica (thallus) extract creatine sodium rna caffeine micrococcus lysate nordihydroguaiaretic acid sodium dna phytosphingosine linoleic acid cholesterol ascorbyl tocopheryl maleate sodium hyaluronate aminopropyl ascorbyl phosphate tocopheryl acetate trisiloxane sucrose laurdimonium hydroxypropyl hydrolyzed soy protein lecithin hexylene glycol ethylhexyl stearate ethylhexyl palmitate decarboxy carnosine hcl propylene glycol dicaprate chamomilla recutita (matricaria) zeolite caprylyl glycol polyethylene xanthan gum laureth-4 laureth-23 polysorbate 20 ammonium acryloyldimethyltaurate/vp copolymer acrylic acid/vp crosspolymer arginine ferulate tromethamine disodium edta phenoxyethanol [iln37043]

Other information

protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

© CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

CLINIQUE

superdefense

age defense moisturizer
broad spectrum SPF 25

COMBINATION OILY TO OILY

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE   SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25
avobenzone, octisalate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-709
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.3 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
WHEAT BRAN (UNII: 6L966A1IMR)
saccharina latissima thallus (UNII: 68CMP2MB55)
BLACK OLIVE (UNII: 2M6QWV94OC)
ROBUSTA COFFEE BEAN (UNII: V5032728L7)
ECHINACEA PALLIDA (UNII: 904CK3270L)
ROSEMARY (UNII: IJ67X351P9)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
TREHALOSE (UNII: B8WCK70T7I)
PADINA PAVONICA (UNII: 177U06NHZI)
CREATINE (UNII: MU72812GK0)
CAFFEINE (UNII: 3G6A5W338E)
MASOPROCOL (UNII: 7BO8G1BYQU)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRISILOXANE (UNII: 9G1ZW13R0G)
SUCROSE (UNII: C151H8M554)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURETH-4 (UNII: 6HQ855798J)
LAURETH-23 (UNII: N72LMW566G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TROMETHAMINE (UNII: 023C2WHX2V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-709-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2004

Labeler - CLINIQUE LABORATORIES INC (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL(49527-709) , REPACK(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(49527-709) , RELABEL(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-709)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(49527-709)